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<p>The primary goal of this research was to develop and optimise PNIPAAm-based in-situ nasal gels for ensifentrine delivery, aiming to enhance drug bioavailability, retention time, and therapeutic outcomes for the treatment of COPD and asthma. The formulation was optimized using a 3² full factorial design, with the independent variables being the concentrations of PNIPAAm (1%, 3%, 5% w/v) and HPMC K4M (0.2%, 0.4%, 0.6% w/v). The dependent variables included gelation temperature, mucoadhesive strength, and drug release. Various characterization techniques including solubility studies, DSC, FTIR, viscosity, and ex-vivo permeation were employed to assess the performance of the nasal gel. The study showed that ensifentrine achieved its maximum solubility value in phosphate buffer solution at pH 6.4 (3.02 ± 0.05 mg/mL). The gelation temperature range was 27.1–34.2 °C and the mucoadhesive strength extended from 0.98 N/cm² to 2.72 N/cm². Formulation MF7 demonstrated the highest drug permeation rate achieving 91.7 ± 3.1% of cumulative drug delivery over an 8-hour ex vivo permeation study. The formulation stability test showed no considerable modifications during Six months of accelerated storage. The PNIPAAm-based nasal gel formulation shows outstanding potential for maintaining drug release duration together with increased ensifentrine bioavailability. The favorable mucoadhesive and gelation properties of formulation MF7 provide evidence that it can serve as a potential alternative for improving drug systemic absorption through nasal administration for future clinical applications in chronic respiratory disease treatment.</p>

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Development and Optimization of PNIPAAm Based Ensifentrine Loaded In-situ Nasal Gel for Improved Bioavailability

  • 期刊论文

  • 发表日期：

    2026年3月17日

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  • Mahesh Sadgir,
  • Rahulkumar Rahane,
  • Vaibhav Andhale

摘要

The primary goal of this research was to develop and optimise PNIPAAm-based in-situ nasal gels for ensifentrine delivery, aiming to enhance drug bioavailability, retention time, and therapeutic outcomes for the treatment of COPD and asthma. The formulation was optimized using a 3² full factorial design, with the independent variables being the concentrations of PNIPAAm (1%, 3%, 5% w/v) and HPMC K4M (0.2%, 0.4%, 0.6% w/v). The dependent variables included gelation temperature, mucoadhesive strength, and drug release. Various characterization techniques including solubility studies, DSC, FTIR, viscosity, and ex-vivo permeation were employed to assess the performance of the nasal gel. The study showed that ensifentrine achieved its maximum solubility value in phosphate buffer solution at pH 6.4 (3.02 ± 0.05 mg/mL). The gelation temperature range was 27.1–34.2 °C and the mucoadhesive strength extended from 0.98 N/cm² to 2.72 N/cm². Formulation MF7 demonstrated the highest drug permeation rate achieving 91.7 ± 3.1% of cumulative drug delivery over an 8-hour ex vivo permeation study. The formulation stability test showed no considerable modifications during Six months of accelerated storage. The PNIPAAm-based nasal gel formulation shows outstanding potential for maintaining drug release duration together with increased ensifentrine bioavailability. The favorable mucoadhesive and gelation properties of formulation MF7 provide evidence that it can serve as a potential alternative for improving drug systemic absorption through nasal administration for future clinical applications in chronic respiratory disease treatment.